FDA 510(k) Application Details - K120865

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K120865
Device Name	Electrocardiograph
Applicant	MORTARA INSTRUMENT, INC 7865 NORTH 86TH STREET MILWAUKEE, WI 53224 US Other 510(k) Applications for this Company
Contact	CHARLES MORREALE Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2012
Decision Date	07/19/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review